NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

NCT06785831 | Not Yet Recruiting

• 2 other identifiers: KME 0120-242/2024-2711-4L7-50154
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of different foods to normal bowel function in adult population will be investigated. A randomised controlled intervention trial will be conducted on about 120 (30 per group) adult (18-70 years) subjects with functional constipation and irritable bowel syndrome with constipation according to the IV. Rome criteria. At least one week before inclusion in the study, patients will stop taking laxatives and other anti-constipation medications. Subjects will be randomly selected to consume one of the test foods (fresh apples, dried apples, sauerkraut) or the active control (psyllium) in the equivalent amount of 3 g of fiber per day for 4 weeks. Subjects will be asked not to change their lifestyle habits, such as diet and physical activity level, and not to take oral laxatives during the period of participation in the study.

Conditions

Functional Constipation; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in frequency of complete spontaneous bowel movements (CSBM) / week

  Daily measurement of number of complete spontaneous bowel movements

  fourth week vs pre-intervention

Other Outcomes (3)

• Change in constipation symptom score (CSC)

  fourth week vs pre-intervention

• Change in stool consistency using Bristol stool form (BSF) scale

  fourth week vs pre-intervention

• Change in blood lipids

  in week after intervention vs pre-intervention

Study Arms (4)

Psyllium

ACTIVE COMPARATOR

Psyllium containing 3 g dietary fibre, daily, for 4 weeks

Other: Psyllium

Sauerkraut

EXPERIMENTAL

Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks

Other: Sauerkraut

Fresh apples

EXPERIMENTAL

Fresh apples containing 3 g dietary fibre, daily, for 4 weeks

Other: Fresh apples

Dried apples

EXPERIMENTAL

Dried apples containing 3 g dietary fibre, daily, for 4 weeks

Other: Dried apples

Interventions

Psyllium OTHER

Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days.

Psyllium

Sauerkraut OTHER

Participants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days.

Sauerkraut

Fresh apples OTHER

Participants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days.

Fresh apples

Dried apples OTHER

Participants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days.

Dried apples

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent of the participant to participate in the study
• Age between 18 and 70 years
• Functional constipation or irritable bowel syndrome
• Expressed willingness to eat the investigated food daily (sauerkraut, apples, dried apples or psyllium; period of four weeks)

You may not qualify if:

• Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium)
• Pregnancy or breastfeeding
• Previous gastrointestinal surgery with the exception of cholecystectomy and appendectomy
• Other gastrointestinal diseases (chronic inflammatory bowel disease, celiac disease, gastroparesis, etc.)
• Serious chronic diseases
• Regular use of laxatives or inability to stop using laxatives for the duration of the study
• Concurrent participation in another study

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• University Medical Centre Ljubljana: collaborator
• University of Ljubljana: collaborator

Study Sites (1)

UKC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Anita Kušar, PhD

  Researcher

  STUDY DIRECTOR

Central Study Contacts

Anita Kušar, PhD

CONTACT

0038659068870; anita.kusar@nutris.org

Igor Pravst, PhD

CONTACT

0038659068871; igor.pravst@nutris.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Intervention include consumption of specific foods, therefore masking to participant and investigatior is not possible. Collected data will be masked for accessor of outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 21, 2025
• Study Start: January 20, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

SL (1)